Infrapopliteal Drug Eluting Angioplasty Versus Stenting (IDEAS-I)

This study has been completed.

Sponsor:

University of Patras

ClinicalTrials.gov Identifier:

NCT01517997

First Posted: January 25, 2012

Last Update Posted: October 9, 2013

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In total 50 patients diagnosed with long-segment infrapopliteal arterial disease will be randomized in two groups. The patients randomized in the Drug coated balloons (DCB) study arm will undergo a percutaneous transluminal angioplasty (PTA) with the use of a paclitaxel-coated balloon, while the patients randomized in the drug-eluting stent (DES) study arm will undergo primary stenting using drug-eluting stent(s). The study's primary endpoints will be the 6-month angiographic binary restenosis rate. Secondary endpoints will include the immediate technical success,6-month primary patency, target lesion revascularization and limb salvage and complication rates.

Patients included in this arm will undergo PTA with the use of a paclitaxel coated balloon.

Procedure: Paclitaxel coated balloon angioplasty.

Infrapopliteal angioplasty using a paclitaxel coated balloon.

Other Name: DCB

Active Comparator: Drug Eluting Stents (DES) Arm

Patients in this arm will undergo primary infrapopliteal stenting of the target lesion using a drug-eluting stent.

Procedure: Infrapopliteal Primary Drug Eluting Stenting

Infrapopliteal primary stenting using drug-eluting stent(s)

Other Name: DES

Detailed Description:

Patients programmed to undergo PTA due to angiographically-proven infrapopliteal arterial disease in our department will be randomized in the above mentioned study arms. The studies primary endpoint will be assessed with the use of intra-arterial digital subtracted angiography and subsequent Quantitative Vascular Analysis (QVA) analysis.Clinical follow-up is set at 1, 3 and 6 months. Patients' baseline demographics and procedural details will be recorded and analyzed.

Eligibility

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